Polyethylene glycol hydrogel spinal sealant (DuraSeal spinal sealant) as an adjunct to sutured dural repair in the spine

Results of a prospective, multicenter, randomized controlled study

Kee D Kim, Neill M. Wright

Research output: Contribution to journalArticle

60 Citations (Scopus)

Abstract

Study Design.: A prospective, multicenter, randomized, two-arm, single-blind, investigational device exemption pivotal study. Objective.: To assess the efficacy and the safety of a polyethylene glycol (PEG) hydrogel spinal sealant (DuraSeal Spinal Sealant) as an adjunct to sutured dural repair compared with standard of care methods (control) to obtain a watertight dural closure in patients undergoing an intentional durotomy during spinal surgery. Summary of Background Data.: If a watertight dural closure is not achieved, cerebrospinal fluid leak with associated complications may occur. The PEG hydrogel spinal sealant is an Food and Drug Administration (FDA)-approved adjunct to sutured dural repair in spine surgery. This synthetic, absorbable hydrogel sealant works in the presence of fluid, conforms to irregular surfaces, and demonstrates strong adherence and compliance to tissue, without interfering with underlying tissue visibility. Methods.: A total of 158 patients were treated at 24 centers after they were randomized on the basis of an approximately 2:1 ratio (sealant:control); 102 received the PEG hydrogel spinal sealant and 56 received standard care. The primary end point was intraoperative watertight closure. Secondary end points included evaluations of postoperative cerebrospinal fluid leak, infection, and wound healing. Results.: Patients treated with the PEG hydrogel spinal sealant had a significantly higher rate of watertight closure than the control (100% vs. 64.3%, P < 0.001). No statistical differences were seen in postoperative cerebrospinal fluid leak, infection, and wound healing. No neurologic deficits were seen attributable to the sealant. Conclusion.: The PEG hydrogel spinal sealant evaluated in this study is safe and effective for providing watertight closure when used as an adjunct to sutured dural repair during spinal surgery. This readily available tool is superior to other standard of care technologies commonly used to achieve intraoperative watertight dural closure.

Original languageEnglish (US)
Pages (from-to)1906-1912
Number of pages7
JournalSpine
Volume36
Issue number23
DOIs
StatePublished - Nov 1 2011

Fingerprint

Hydrogel
Spine
Standard of Care
Wound Healing
United States Food and Drug Administration
Neurologic Manifestations
Infection
DuraSeal spinal sealant
Technology
Safety
Equipment and Supplies
Cerebrospinal Fluid Leak

Keywords

  • DuraSeal spinal sealant
  • efficacy
  • PEG hydrogel sealant
  • safety
  • watertight dural closure

ASJC Scopus subject areas

  • Clinical Neurology
  • Orthopedics and Sports Medicine

Cite this

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title = "Polyethylene glycol hydrogel spinal sealant (DuraSeal spinal sealant) as an adjunct to sutured dural repair in the spine: Results of a prospective, multicenter, randomized controlled study",
abstract = "Study Design.: A prospective, multicenter, randomized, two-arm, single-blind, investigational device exemption pivotal study. Objective.: To assess the efficacy and the safety of a polyethylene glycol (PEG) hydrogel spinal sealant (DuraSeal Spinal Sealant) as an adjunct to sutured dural repair compared with standard of care methods (control) to obtain a watertight dural closure in patients undergoing an intentional durotomy during spinal surgery. Summary of Background Data.: If a watertight dural closure is not achieved, cerebrospinal fluid leak with associated complications may occur. The PEG hydrogel spinal sealant is an Food and Drug Administration (FDA)-approved adjunct to sutured dural repair in spine surgery. This synthetic, absorbable hydrogel sealant works in the presence of fluid, conforms to irregular surfaces, and demonstrates strong adherence and compliance to tissue, without interfering with underlying tissue visibility. Methods.: A total of 158 patients were treated at 24 centers after they were randomized on the basis of an approximately 2:1 ratio (sealant:control); 102 received the PEG hydrogel spinal sealant and 56 received standard care. The primary end point was intraoperative watertight closure. Secondary end points included evaluations of postoperative cerebrospinal fluid leak, infection, and wound healing. Results.: Patients treated with the PEG hydrogel spinal sealant had a significantly higher rate of watertight closure than the control (100{\%} vs. 64.3{\%}, P < 0.001). No statistical differences were seen in postoperative cerebrospinal fluid leak, infection, and wound healing. No neurologic deficits were seen attributable to the sealant. Conclusion.: The PEG hydrogel spinal sealant evaluated in this study is safe and effective for providing watertight closure when used as an adjunct to sutured dural repair during spinal surgery. This readily available tool is superior to other standard of care technologies commonly used to achieve intraoperative watertight dural closure.",
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author = "Kim, {Kee D} and Wright, {Neill M.}",
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T2 - Results of a prospective, multicenter, randomized controlled study

AU - Kim, Kee D

AU - Wright, Neill M.

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N2 - Study Design.: A prospective, multicenter, randomized, two-arm, single-blind, investigational device exemption pivotal study. Objective.: To assess the efficacy and the safety of a polyethylene glycol (PEG) hydrogel spinal sealant (DuraSeal Spinal Sealant) as an adjunct to sutured dural repair compared with standard of care methods (control) to obtain a watertight dural closure in patients undergoing an intentional durotomy during spinal surgery. Summary of Background Data.: If a watertight dural closure is not achieved, cerebrospinal fluid leak with associated complications may occur. The PEG hydrogel spinal sealant is an Food and Drug Administration (FDA)-approved adjunct to sutured dural repair in spine surgery. This synthetic, absorbable hydrogel sealant works in the presence of fluid, conforms to irregular surfaces, and demonstrates strong adherence and compliance to tissue, without interfering with underlying tissue visibility. Methods.: A total of 158 patients were treated at 24 centers after they were randomized on the basis of an approximately 2:1 ratio (sealant:control); 102 received the PEG hydrogel spinal sealant and 56 received standard care. The primary end point was intraoperative watertight closure. Secondary end points included evaluations of postoperative cerebrospinal fluid leak, infection, and wound healing. Results.: Patients treated with the PEG hydrogel spinal sealant had a significantly higher rate of watertight closure than the control (100% vs. 64.3%, P < 0.001). No statistical differences were seen in postoperative cerebrospinal fluid leak, infection, and wound healing. No neurologic deficits were seen attributable to the sealant. Conclusion.: The PEG hydrogel spinal sealant evaluated in this study is safe and effective for providing watertight closure when used as an adjunct to sutured dural repair during spinal surgery. This readily available tool is superior to other standard of care technologies commonly used to achieve intraoperative watertight dural closure.

AB - Study Design.: A prospective, multicenter, randomized, two-arm, single-blind, investigational device exemption pivotal study. Objective.: To assess the efficacy and the safety of a polyethylene glycol (PEG) hydrogel spinal sealant (DuraSeal Spinal Sealant) as an adjunct to sutured dural repair compared with standard of care methods (control) to obtain a watertight dural closure in patients undergoing an intentional durotomy during spinal surgery. Summary of Background Data.: If a watertight dural closure is not achieved, cerebrospinal fluid leak with associated complications may occur. The PEG hydrogel spinal sealant is an Food and Drug Administration (FDA)-approved adjunct to sutured dural repair in spine surgery. This synthetic, absorbable hydrogel sealant works in the presence of fluid, conforms to irregular surfaces, and demonstrates strong adherence and compliance to tissue, without interfering with underlying tissue visibility. Methods.: A total of 158 patients were treated at 24 centers after they were randomized on the basis of an approximately 2:1 ratio (sealant:control); 102 received the PEG hydrogel spinal sealant and 56 received standard care. The primary end point was intraoperative watertight closure. Secondary end points included evaluations of postoperative cerebrospinal fluid leak, infection, and wound healing. Results.: Patients treated with the PEG hydrogel spinal sealant had a significantly higher rate of watertight closure than the control (100% vs. 64.3%, P < 0.001). No statistical differences were seen in postoperative cerebrospinal fluid leak, infection, and wound healing. No neurologic deficits were seen attributable to the sealant. Conclusion.: The PEG hydrogel spinal sealant evaluated in this study is safe and effective for providing watertight closure when used as an adjunct to sutured dural repair during spinal surgery. This readily available tool is superior to other standard of care technologies commonly used to achieve intraoperative watertight dural closure.

KW - DuraSeal spinal sealant

KW - efficacy

KW - PEG hydrogel sealant

KW - safety

KW - watertight dural closure

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